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Process inspections and the OECD GLP Principles 过程检查和经合组织GLP原则
Quality Assurance Journal Pub Date : 2007-06-01 DOI: 10.1002/QAJ.418
P. Withers, David Long
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引用次数: 0
Process inspections and the OECD GLP Principles 过程检查和经合组织GLP原则
Quality Assurance Journal Pub Date : 2007-06-01 DOI: 10.1002/QAJ.417
Henry Li, D. Pifat, Gerald L. Klein, S. Petteway
{"title":"Process inspections and the OECD GLP Principles","authors":"Henry Li, D. Pifat, Gerald L. Klein, S. Petteway","doi":"10.1002/QAJ.417","DOIUrl":"https://doi.org/10.1002/QAJ.417","url":null,"abstract":"","PeriodicalId":147931,"journal":{"name":"Quality Assurance Journal","volume":"360 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2007-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"115891249","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Can eTraining be beneficial means for training the staff in QA 培训是培训QA员工的有益手段吗
Quality Assurance Journal Pub Date : 2007-06-01 DOI: 10.1002/QAJ.419
P. C. Constant
{"title":"Can eTraining be beneficial means for training the staff in QA","authors":"P. C. Constant","doi":"10.1002/QAJ.419","DOIUrl":"https://doi.org/10.1002/QAJ.419","url":null,"abstract":"The question is raised as to whether the staff of a company needs to be trained in quality assurance, especially what is relative to one's responsibilities. The answer is inferred to be in the affirmative, and thus training in general is discussed. Questions to be asked before deciding on the type of training that should be undertaken as well as representative areas to be covered in the training are given. The emphasis is on eTraining, giving its advantages and disadvantages; how it can be ensured the staff will accept the training; the effectiveness of the training from business and staff development standpoints; whether eTraining will have a sustained educational effect; how difficult it is to develop a proper curriculum; what start up and continuous costs and what cost/benefit ratio can be expected. Copyright © 2008 John Wiley & Sons, Ltd.","PeriodicalId":147931,"journal":{"name":"Quality Assurance Journal","volume":"139 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2007-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"127473793","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Write it Down – guidance for preparing effective and compliant documentation, 2nd edition, edited by Janet Gough, CRC Press/Taylor & Francis Group, Boca Raton, FL, USA, 2005, 479 p., GBP 130.00, ISBN 0‐8493‐2171‐9 写下来-准备有效和合规文档的指南，第2版，Janet Gough编辑，CRC出版社/Taylor & Francis集团，美国佛罗里达州博卡拉顿，2005年，479页，130.00英镑，ISBN 0‐8493‐2171‐9
Quality Assurance Journal Pub Date : 2007-03-01 DOI: 10.1002/qaj.405
R. Hattemer‐Apostel
{"title":"Write it Down – guidance for preparing effective and compliant documentation, 2nd edition, edited by Janet Gough, CRC Press/Taylor & Francis Group, Boca Raton, FL, USA, 2005, 479 p., GBP 130.00, ISBN 0‐8493‐2171‐9","authors":"R. Hattemer‐Apostel","doi":"10.1002/qaj.405","DOIUrl":"https://doi.org/10.1002/qaj.405","url":null,"abstract":"","PeriodicalId":147931,"journal":{"name":"Quality Assurance Journal","volume":"43 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2007-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"124462537","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 1
A factor in quality: information on client satisfaction/dissatisfaction 质量因素:客户满意/不满意的信息
Quality Assurance Journal Pub Date : 2007-03-01 DOI: 10.1002/QAJ.401
P. C. Constant
{"title":"A factor in quality: information on client satisfaction/dissatisfaction","authors":"P. C. Constant","doi":"10.1002/QAJ.401","DOIUrl":"https://doi.org/10.1002/QAJ.401","url":null,"abstract":"The interrelation of client satisfaction with quality of service or product produced is brought out in the discussion on the importance to know whether a client (customer) is satisfied or dissatisfied with a company's (contractor's) service or product. Nine factors to be considered in determining client satisfaction or dissatisfaction are discussed. An algorithm is given for determining the client's figure of merit, which gives a means for prioritizing clients to be contacted. The nine factors are types of clients, which includes advantages and disadvantages of clients by class and contact comparisons; criteria for selection of clients to be contacted; the four types of contact and considerations for types to use; those to make the contact; when to contact client; contactor training topics; analysis of results of contact findings; documentation of contacts: and follow-up and follow-through activities. Items concerning the contact plan also are given as well as a sample plan. The paper closes with a set of inferred conclusions. Copyright © 2007 John Wiley & Sons, Ltd.","PeriodicalId":147931,"journal":{"name":"Quality Assurance Journal","volume":"19 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2007-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"123207760","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 2
Planning for a solid waste management quality assurance program in Egypt 规划埃及固体废物管理质量保证方案
Quality Assurance Journal Pub Date : 2007-03-01 DOI: 10.1002/QAJ.408
Rehab O. Abdel Rahman, A. M. El-kamash, F. A. Shehata, M. R. El-Sourougy
{"title":"Planning for a solid waste management quality assurance program in Egypt","authors":"Rehab O. Abdel Rahman, A. M. El-kamash, F. A. Shehata, M. R. El-Sourougy","doi":"10.1002/QAJ.408","DOIUrl":"https://doi.org/10.1002/QAJ.408","url":null,"abstract":"Over the past 40 years, a considerable amount of solid radioactive waste has been generated in Egypt from a variety of nuclear technology applications in research, medicine, and industry. The Hot Laboratory and Waste Management Center at Inshas, Cairo, has started to build an integrated waste management system to ensure the safe management of this radioactive waste. During the establishment of this system, a range of technological options have been identified and evaluated in order to select and justify the most appropriate option for each waste type, taking into account the basic waste management principles, regulatory requirements, available resources, and other technical and non-technical factors. Unfortunately, some of the generated wastes were not under a Quality Assurance Program that provides maintenance of traceability to production or conditioning records. So, these wastes are considered unacceptable to be placed in the disposal facility and need to be characterized and brought to an acceptable condition prior to disposal. This must be done in accordance with comprehensive plans and documented procedures to guarantee the safe handling, storage, and disposal. In this work, the existing Egyptian solid waste management system will be presented with a special reference to a management plan to be applied through this system. This will include a description of the organizational structure, functional responsibilities, organizational interfaces, personnel training, documentation, and corrective action. Copyright © 2007 John Wiley & Sons, Ltd.","PeriodicalId":147931,"journal":{"name":"Quality Assurance Journal","volume":"12 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2007-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"121901785","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 8
Belmont Revisited – ethical principles for research with human subjects, edited by James F. Childress, Eric M. Meslin, Harold T. Shapiro, Georgetown University Press, Washington, DC, USA, 2005, 296 p., USD 29.95, ISBN 1‐58901‐062‐0 贝尔蒙特重访——人类受试者研究的伦理原则，詹姆斯·f·柴尔德里斯、埃里克·m·梅斯林、哈罗德·t·夏皮罗主编，乔治敦大学出版社，华盛顿特区，美国，2005年，296页，29.95美元，ISBN 1‐58901‐062‐0
Quality Assurance Journal Pub Date : 2007-03-01 DOI: 10.1002/QAJ.406
N. Tueller
{"title":"Belmont Revisited – ethical principles for research with human subjects, edited by James F. Childress, Eric M. Meslin, Harold T. Shapiro, Georgetown University Press, Washington, DC, USA, 2005, 296 p., USD 29.95, ISBN 1‐58901‐062‐0","authors":"N. Tueller","doi":"10.1002/QAJ.406","DOIUrl":"https://doi.org/10.1002/QAJ.406","url":null,"abstract":"","PeriodicalId":147931,"journal":{"name":"Quality Assurance Journal","volume":"61 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2007-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"131524897","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Test article analyses in compliance with good laboratory practice in Japan: circumstances and changes 符合日本良好实验室规范的测试品分析:情况和变化
Quality Assurance Journal Pub Date : 2007-03-01 DOI: 10.1002/QAJ.404
Harumi Namiki, Tetsuya Shigeta, Y. Ino, Kanzo Kimura, K. Inaba, S. Kawasaki, Yasuhide Kitazaki, S. Imada
{"title":"Test article analyses in compliance with good laboratory practice in Japan: circumstances and changes","authors":"Harumi Namiki, Tetsuya Shigeta, Y. Ino, Kanzo Kimura, K. Inaba, S. Kawasaki, Yasuhide Kitazaki, S. Imada","doi":"10.1002/QAJ.404","DOIUrl":"https://doi.org/10.1002/QAJ.404","url":null,"abstract":"In Japan, many test facilities have been inspected by the monitoring agency since 1984 and inspectors pointed out some issues for improvement. The interest in test article analyses in support of Good Laboratory Practice (GLP)-compliant studies has been rising for the last several years. This paper reports the advice and indications for improvement that were pointed out for test article analyses by the Japanese monitoring agency. In addition, the Japan Society of Quality Assurance (JSQA) conducted surveys using a questionnaire form in 2001 and 2004 in order to understand the present situation and the changes in Japanese test facilities that belong to the member companies of the GLP division of the JSQA. From the results of surveys, it was found that test article analyses have been performed under GLP, reflecting the requirements of the monitoring agency. Copyright © 2007 John Wiley & Sons, Ltd.","PeriodicalId":147931,"journal":{"name":"Quality Assurance Journal","volume":"44 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2007-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"130508431","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Current challenges for FDA‐regulated bioanalytical laboratories for human (BA/BE) studies. Part I: defining the appropriate compliance standards – application of the principles of FDA GLP and FDA GMP to bioanalytical laboratories FDA监管的人(BA/BE)研究生物分析实验室当前面临的挑战。第一部分:定义适当的合规标准- FDA GLP和FDA GMP原则在生物分析实验室中的应用
Quality Assurance Journal Pub Date : 2007-03-01 DOI: 10.1002/QAJ.399
A. Ocampo, Steven J. K. Lum, Frank Chow
{"title":"Current challenges for FDA‐regulated bioanalytical laboratories for human (BA/BE) studies. Part I: defining the appropriate compliance standards – application of the principles of FDA GLP and FDA GMP to bioanalytical laboratories","authors":"A. Ocampo, Steven J. K. Lum, Frank Chow","doi":"10.1002/QAJ.399","DOIUrl":"https://doi.org/10.1002/QAJ.399","url":null,"abstract":"This article is the first of a three-part series that deals with current compliance issues/challenges for bioanalytical laboratories performing analysis for bioavailability/bioequivalence studies. Part 1 of this series provides the application of key elements from the Food and Drug Administration Good Laboratory Practices and the current Good Manufacturing Practices regulations as the framework for the implementation of sound quality systems in a bioanalytical laboratory to be in compliance with current regulatory expectations. Copyright © 2007 John Wiley & Sons, Ltd.","PeriodicalId":147931,"journal":{"name":"Quality Assurance Journal","volume":"15 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2007-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"121375432","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 9
Complaint handling in pharmaceutical companies 制药公司投诉处理
Quality Assurance Journal Pub Date : 2007-03-01 DOI: 10.1002/QAJ.398
G. Braga
{"title":"Complaint handling in pharmaceutical companies","authors":"G. Braga","doi":"10.1002/QAJ.398","DOIUrl":"https://doi.org/10.1002/QAJ.398","url":null,"abstract":"Complaints show customer dissatisfaction about the quality of a pharmaceutical product. Despite a regulatory obligation in several countries, a good complaint handling system gives the company an opportunity to improve the quality of their products, being a good tool for the maintenance of Good Manufacturing Practices and a way to establish a committed relationship with their customers. A systematic procedure must be developed and implemented in order to register and investigate each complaint received and not only the Quality Assurance area must be involved. This process must involve other critical areas such as Marketing, Production, Quality Control, Finance, Regulatory and Legal Affairs. Thus the aim of this article is to discuss the main steps of a good complaint handling procedure that can be readily implemented in pharmaceutical companies. Copyright © 2007 John Wiley & Sons, Ltd.","PeriodicalId":147931,"journal":{"name":"Quality Assurance Journal","volume":"16 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2007-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"123746918","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 5
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